A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Lactams; Peginterferon alfa-2a; Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• Adult patients, 18 to 65 years of age inclusive

• Chronic hepatitis C, genotype 1 or 4

• Cohort 1: Treatment-naïve for hepatitis C

• Cohort 2: Prior null responder to treatment with approved doses of pegylated interferon plus ribavirin

• Liver biopsy confirming cirrhosis

• Compensated cirrhosis (Child-Pugh A)

Exclusion Criteria:

• Pregnant or lactating women or male partners of women who are pregnant

• History or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)

• Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response

• History of clinically significant cardiovascular or cerebrovascular disease